Argatroban Injection — Class III drug recall D-0980-2017
Terminated recall by Hospira Inc., A Pfizer Company, reported 2017-07-26, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurit
| Recall number | D-0980-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., A Pfizer Company, Lake Forest, IL, United States |
| Recall initiated | 2017-07-06 |
| Classified | 2017-07-14 |
| Reported by FDA | 2017-07-26 |
| Terminated | 2019-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 701 vials |
| Reason classes | specification failure |
| NDC | 00409-1140-01 |
| Lot numbers | DP601 |
| Expiration dates | 2018-10 |
Product
Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad, India, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 --- NDC 0409-1140-01
Reason for recall
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0980-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.